Apparatus and methods for correcting nasal valve collapse

ABSTRACT

The present invention relates to apparatus ad methods for correcting nasal valve collapse comprising a device configured for suspending a nasal valve, the device comprising a body portion comprising a proximal end, a distal end, and a plurality of barbs, wherein the body portion is configured to be inserted through or underneath the upper lateral cartilage of a patient and wherein the plurality of barbs are configured to engage a soft tissue overlying a bony tissue proximal to the upper lateral cartilage, and a head portion coupled to the proximal end of the body portion wherein the head portion is configured to engage the upper lateral cartilage of the patient when the plurality of barbs are engaged with the soft tissue overlying the bony tissue proximal to the upper lateral cartilage

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/116,112, filed Nov. 19, 2008, entitled “Apparatus andMethods for Correcting Nasal Valve Collapse”, the entire disclosure ofwhich is specifically incorporated herein by reference.

FIELD OF THE INVENTION

The present disclosure relates generally to devices, systems and methodsfor correcting a nasal valve collapse and/or stabilizing lateral nasalcartilage.

BACKGROUND INFORMATION

Nasal valve collapse is a frequent and sufficient cause of nasal airwayobstruction, characterized by a loss of support from lateral nasalcartilages typically observed following rhinoplasty, nasal trauma or inaged patients. Properly functioning nasal cartilage acts to keep thenasal passages open. If the lateral cartilages become weak, theycollapse inward when a person inhales due to the negative pressure fromthe flow of air. This problem is currently largely untreated due to thecomplexity and highly variable results associated with current repairtechniques, combined with the fact that a majority of patients areelderly or have a history of nasal surgery. These complex surgicalprocedures have been developed to correct valve collapse by reinforcingthe lateral cartilages so adequate support can permit valve opening andthus eliminate the nasal airway obstruction.

However, many of these procedures require surgically opening the nose toreplace structurally insufficient tissue with either synthetic orautologous tissue grafts. Results of these procedures have been highlyvariable and drawbacks include the lack of sufficient autologousgrafting tissue, significant infection and extrusion of syntheticgrafts, the potential for altering facial aesthetics and possibleconfounding effects on other nasal functionality. Another method forrepairing nasal valve collapse, developed by Friedman et al., involves abone-anchor suspension technique whereby a suture is anchored to theorbital rim and placed subcutaneously so as to loop through the upperlateral cartilage. Instead of imparting structural integrity to thecollapsed cartilage, it applies tensile forces through this suture toprevent further collapse. Although the procedure has shown some promise,very few surgeons perform the technique because of the technicaldifficulties and potential complications. Complications occur becausepatients develop granulomas due to suture proximity to the nasal mucosa,which eventually necessitates implant removal.

Overall, nasal valve collapse is an oftentimes untreated problem due toinconsistent results from a myriad of very complex procedures performedby very few surgeons. As such, there remains a need for an endoscopicmethod to repair nasal valve in a simple, consistent manner.

SUMMARY

Exemplary embodiments of the present disclosure comprise a deviceconfigured for suspending a nasal valve. In certain embodiments, thedevice comprises a body portion comprising a proximal end, a distal end,and a plurality of barbs. The body portion can be configured to beinserted through or underneath the upper lateral cartilage of a patientand the plurality of barbs configured to engage the soft tissueoverlying bony tissue proximal to the upper lateral cartilage. Certainembodiments may comprise a head portion coupled to the proximal end ofthe body portion, where the head portion is configured to engage theupper lateral cartilage of the patient when the plurality of barbs areengaged with the soft tissue overlying bony tissue proximal to the upperlateral cartilage.

In certain embodiments, the head portion is coupled to the body portionto form a “T” shape, while in other embodiments the head portion iscoupled to the body portion to form an “L” shape or a hook shape. Theplurality of barbs can be distributed along one side of the body portionand may be directed toward the proximal end of the body portion. Inspecific embodiments, the body portion and head portion are separated byan angle of between 90 and 120 degrees, more specifically between 95 and115 degrees, and more specifically still between 100 and 110 degrees. Incertain other embodiments, the body portion and head portion areseparated by an angle of between 60 and 20 degrees, more specificallybetween 55 and 25 degrees, and more specifically still between 50 and 30degrees.

Other embodiments comprise a method of stabilizing the upper lateralcartilage of a patient. The method may comprise: creating an aperture inthe mucosa of the patient; inserting a device with a body portion and ahead portion into the aperture, where the body portion of the device isinserted into the aperture prior to the head portion; advancing thedevice into the aperture so that the head portion engages the upperlateral cartilage of the patient; and engaging the plurality of barbsinto soft tissue overlying the bony tissue proximal to the upper lateralcartilage. Specific embodiments may include engaging the plurality ofbarbs into soft tissue overlying the bony tissue lateral to the upperlateral cartilage, including, for example, the maxilla of the patient.

In certain embodiments, the body portion of the device pierces the upperlateral cartilage of the patient, and in other embodiments the bodyportion of the device is inserted between the upper lateral cartilage ofthe patient and bony tissue proximal to the upper lateral cartilage. Inspecific embodiments, the device is inserted into the aperture using aguiding needle sheath.

In certain embodiments, engaging the plurality of barbs into the softtissue overlying the bony tissue proximal to the upper lateral cartilageof the patient comprises pressing down on an epidermal tissue proximalto the device. In specific embodiments, the soft tissue overlying thebony tissue is part of the orbital bone, while in other embodiments, thebony tissue is part of the nasal bone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a nasal valve suspension deviceaccording to an exemplary embodiment of the present disclosure.

FIG. 2 illustrates a perspective view of the embodiment of FIG. 1 in anexemplary installed position.

FIG. 3 illustrates a perspective view of a nasal valve suspension deviceaccording to an exemplary embodiment of the present disclosure.

FIG. 4 illustrates a perspective view of the embodiment of FIG. 2 in anexemplary installed position.

FIG. 5 illustrates side and top views of a nasal valve suspension deviceaccording to an exemplary embodiment of the present disclosure.

FIG. 6 illustrates side and top views of a nasal valve suspension deviceaccording to an exemplary embodiment of the present disclosure.

FIG. 7 illustrates a front view of the embodiment of FIG. 5 in anexemplary installed position.

FIG. 8 illustrates a side view of the embodiment of FIG. 5 in anexemplary installed position.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring initially to the exemplary embodiment shown in FIG. 1, a nasalvalve suspension device (NVSD) 100 is configured in a “T”-shapecomprising a head portion 110 and a body portion 120 having a proximalend 122 and a distal end 124. A plurality of barbs 130 are disposedalong body portion 120 so that the pointed ends of each barb aredirected towards proximal end 122 (and head portion 110) and away fromdistal end 124. In certain embodiments, body portion 120 may be 0.5 to3.0 cm in length, and head portion 110 may be approximately 0.5centimeters in length.

In exemplary embodiments, intranasal endoscopic placement of NVSD 100may be employed to allow NVSD 100 to support the nasal cartilage andprevent collapse of the nasal valve. In certain embodiments NVSD 100 maycomprise a non-bioabsorbable material. In other embodiments, NVSD 100may comprise a bioabsorbable material. Based on the material used toconstruct NVSD 100, the device can provide structural support while newtissue attachments are formed, and NVSD 100 may remain or degrade overtime.

Referring now to FIG. 2, NVSD 100 may be installed in an intranasalmethod by forming a slit or aperture 170 in the mucosa of a patient.Aperture 170 should be sized large enough to allow NVSD 100, includinghead portion 110, to pass through aperture 170. NVSD 100 can be insertedthrough aperture 170 so that body portion 120 is first inserted and headportion 110 follows. In this embodiment, NVSD 100 is oriented so thatbarbs 130 are facing down (e.g. towards the bone underlying the upperlateral cartilage and away from the epidermis). Body portion 120 canthen be advanced to penetrate the upper lateral cartilage of the patientuntil head portion 110 engages the upper lateral cartilage. NVSD 100 canthen be further advanced until head portion 110 exerts the desiredamount of tension on the upper lateral cartilage.

When the desired amount of tension has been exerted on the upper lateralcartilage, the surgeon can press down on the epidermis above NVSD 100 sothat barbs 130 engage the periosteum of the bone tissue lying lateral tothe upper lateral cartilage (e.g., the orbital bone). When the surgeonreleases the pressure exerted on NVSD 100, barbs 130 will remain engagedwith the periosteum and will maintain the position of NVSD 100. Headportion 110 of NVSD 100 will continue to maintain a force exerted on theupper lateral cartilage and will stabilize the lateral cartilage (e.g.,restrict the upper lateral cartilage from deflecting inwards) when thepatient inhales.

Other embodiments of an NVSD may comprise a different configuration fromthat shown in FIGS. 1-2. Referring now to FIGS. 3-4, another exemplaryembodiment of an NVSD is configured generally as a hook shape ratherthan the “T” shape of the previous embodiment. In the embodiment shownin FIGS. 3-4, NVSD 200 comprises a head portion 210 and a body portion220 having a proximal end 222 and a distal end 224. Head portion 210 andbody portion 220 are spaced apart from each other at an angle 215. Incertain embodiments, angle 215 is between approximately 60 degrees and20 degrees. In specific embodiments, angle 215 is between 55 degrees and25 degrees, and in more specific embodiments angle 215 is between 50 and40 degrees. A plurality of barbs 230 are disposed along body portion 220so that the pointed ends of each barb are directed towards proximal end222 (and head portion 210) and away from distal end 224.

As shown in FIG. 4, this embodiment can be installed through a mucosalaperture 270 so that NVSD 200 either penetrates or is placed above thesuperior aspect of the upper lateral cartilage. NVSD 200 can beinstalled so that body portion 220 is inserted first and barbs 230 arefacing towards the bony tissue of the nasal bone. The surgeon canadvance NVSD 200 so that head portion 210 engages the upper lateralcartilage. When the desired amount of tension has been placed on theupper lateral cartilage, the surgeon can press down on the epidermisabove NVSD 200 so that barbs 230 engage the periosteum of the bonetissue below. Both NVSD 200 and NVSD 300 may be installed in either ofthe positions shown in FIGS. 2 and 4.

Referring now to FIG. 5, another exemplary embodiment of an NVSD issimilar to that shown in FIG. 3, but comprises generally an “L” shape(when viewed from the side), rather than a “hook” shape. In theembodiment shown in FIG. 5, NVSD 300 comprises a head portion 310, abody portion 320 having a proximal end 322 and a distal end 324. Headportion 310 and body portion 320 are spaced apart from each other at anangle 315. In certain embodiments, angle 315 is between approximately 90degrees and 120 degrees. In specific embodiments, angle 315 is between95 degrees and 115 degrees, and in more specific embodiments angle 315is between 100 and 110 degrees. A plurality of barbs 330 are disposedalong body portion 320 so that the pointed ends of each barb aredirected towards proximal end 322 (and head portion 310) and away fromdistal end 324.

Referring now to FIG. 6, another exemplary embodiment of an NVSD issimilar to that shown in FIG. 5, but comprises a head portion 410 thatis slightly curved. NVSD 400 comprises head portion 410, a body portion420 having a proximal end 422 and a distal end 424. Head portion 410 andbody portion 420 are spaced apart from each other at an angle 415. Aplurality of barbs 430 are disposed along body portion 420 so that thepointed ends of each barb are directed towards proximal end 422 (andhead portion 410) and away from distal end 424. The embodiment in FIG. 6can be installed in the same manner as the embodiment of FIG. 5,described below.

As shown in FIGS. 7 and 8, NVSD 300 can be installed so that bodyportion 320 is installed through an aperture 570 in upper lateralcartilage 501. Also visible in FIGS. 7 and 8 are lower lateral cartilage502 and accessory cartilage 503. Head portion 310, however, does notextend through aperture 570, but instead remains under upper lateralcartilage 501. Body portion 320 is inserted through aperture 570sufficiently for head portion 310 to engage upper cartilage 501. Duringinstallation, body portion 320 is oriented so that barbs 330 are facingtowards the bone tissue proximal to body portion 320. Similar toprevious embodiments, the surgeon can press down on the epidermis aboveNVSD 300 so that barbs 330 engage the periosteum of the bone tissuelying lateral to the upper lateral cartilage 501 (e.g., the orbitalbone).

When the surgeon releases the pressure exerted on NVSD 300, barbs 330will remain engaged with the periosteum and will maintain the positionof NVSD 300. Head portion 310 of NVSD 300 will continue to maintain aforce exerted on upper lateral cartilage 501 and will restrict upperlateral cartilage 501 from deflecting inwards when the patient inhales.Angle 315 between head portion 310 and body portion 320 is configured sothat head portion 310 maintains a sufficient force on upper lateralcartilage 501 to restrict deflection during inhalation.

As demonstrated in the above-described devices and methods, exemplaryembodiments of this disclosure can be implemented to support nasalcartilage and keep the nasal passages open, particularly duringinhalation. Exemplary embodiments utilize barbs that engage theperiosteum of bone tissue proximal to the nasal cartilage and serve tomaintain the device in the desired position. Exemplary devices alsocomprise a portion that engages the nasal cartilage and exerts a forceagainst it that resists the collapse of the cartilage.

EQUIVALENTS AND SCOPE

While an exemplary embodiment is described herein, it will be understoodthat various modifications to the method and apparatus can be madewithout departing from the scope of the present invention. For example,the positions of the control mechanisms may be varied from thoseillustrated. Furthermore, the sequential recitation of steps in anyclaim is not a requirement that the steps be performed in any particularorder, unless otherwise so stated.

The foregoing has been a description of certain non-limiting preferredembodiments of the invention. Those skilled in the art will recognize,or be able to ascertain using no more than routine experimentation, manyequivalents to the specific embodiments of the invention describedherein. Those of ordinary skill in the art will appreciate that variouschanges and modifications to this description may be made withoutdeparting from the spirit or scope of the present invention, as definedin the following claims. For example, the positions of the controlmechanisms may be varied from those illustrated.

In the claims articles such as “a”, “an”, and “the” may mean one or morethan one unless indicated to the contrary or otherwise evident from thecontext. Claims or descriptions that include “or” between one or moremembers of a group are considered satisfied if one, more than one, orall of the group members are present in, employed in, or otherwiserelevant to a given product or process unless indicated to the contraryor otherwise evident from the context. The invention includesembodiments in which exactly one member of the group is present in,employed in, or otherwise relevant to a given product or process. Theinvention also includes embodiments in which more than one, or all ofthe group members are present in, employed in, or otherwise relevant toa given product or process. Furthermore, it is to be understood thatembodiments of the invention encompasses all variations, combinations,and permutations in which one or more limitations, elements, clauses,descriptive terms, etc., from one or more of the claims or from relevantportions of the description is introduced into another claim. Forexample, any claim that is dependent on another claim can be modified toinclude one or more limitations found in any other claim that isdependent on the same base claim. Furthermore, where the claims recite acomposition, it is to be understood that methods of using thecomposition for any of the purposes disclosed herein are included, andmethods of making the composition according to any of the methods ofmaking disclosed herein or other methods known in the art are included,unless otherwise indicated or unless it would be evident to one ofordinary skill in the art that a contradiction or inconsistency wouldarise. In addition, embodiments of the invention encompassescompositions made according to any of the methods for preparingcompositions disclosed herein.

Where elements are presented as lists, e.g., in Markush group format, itis to be understood that each subgroup of the elements is alsodisclosed, and any element(s) can be removed from the group. It is alsonoted that the term “comprising” is intended to be open and permits theinclusion of additional elements or steps. It should be understood that,in general, where the invention, or aspects of the invention, is/arereferred to as comprising particular elements, features, steps, etc.,certain embodiments of the invention or aspects of the inventionconsist, or consist essentially of, such elements, features, steps, etc.For purposes of simplicity those embodiments have not been specificallyset forth in haec verba herein. Thus for each embodiment of theinvention that comprises one or more elements, features, steps, etc.,the invention also provides embodiments that consist or consistessentially of those elements, features, steps, etc.

Where ranges are given, endpoints are included. Furthermore, it is to beunderstood that unless otherwise indicated or otherwise evident from thecontext and/or the understanding of one of ordinary skill in the art,values that are expressed as ranges can assume any specific value withinthe stated ranges in different embodiments of the invention, to thetenth of the unit of the lower limit of the range, unless the contextclearly dictates otherwise. It is also to be understood that unlessotherwise indicated or otherwise evident from the context and/or theunderstanding of one of ordinary skill in the art, values expressed asranges can assume any subrange within the given range, wherein theendpoints of the subrange are expressed to the same degree of accuracyas the tenth of the unit of the lower limit of the range.

In addition, it is to be understood that any particular embodiment ofthe present invention may be explicitly excluded from any one or more ofthe claims. Any embodiment, element, feature, application, or aspect ofthe compositions and/or methods of the invention can be excluded fromany one or more claims. For purposes of brevity, all of the embodimentsin which one or more elements, features, purposes, or aspects isexcluded are not set forth explicitly herein.

The following references are herein incorporated by reference:

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1. A device configured for suspending a nasal valve, the devicecomprising: a body portion comprising a proximal end, a distal end, anda plurality of barbs, wherein the body portion is configured to beinserted through or underneath the upper lateral cartilage of a patientand wherein the plurality of barbs are configured to engage a softtissue overlying a bony tissue proximal to the upper lateral cartilage;and a head portion coupled to the proximal end of the body portion,wherein the head portion is configured to engage the upper lateralcartilage of the patient when the plurality of barbs are engaged withthe soft tissue overlying the bony tissue proximal to the upper lateralcartilage.
 2. The device of claim 1, wherein the head portion is coupledto the body portion to form a “T” shape.
 3. The device of claim 1,wherein the head portion is coupled to the body portion to form an “L”shape.
 4. The device of claim 1, wherein the head portion is coupled tothe body portion to form a hook shape.
 5. The device of claim 1, whereinthe plurality of barbs are distributed along one side of the bodyportion.
 6. The device of claim 1, wherein the plurality of barbs aredirected toward the proximal end of the body portion.
 7. The device ofclaim 1, wherein the body portion and head portion are separated by anangle of between 90 and 120 degrees.
 8. The device of claim 1, whereinthe body portion and head portion are separated by an angle of between100 and 110 degrees.
 9. The device of claim 1, wherein the body portionand head portion are separated by an angle of between 60 and 20 degrees.10. The device of claim 1, wherein the body portion and head portion areseparated by an angle of between 50 and 30 degrees.
 11. The device ofclaim 1, wherein the plurality of barbs are configured to engage thesoft tissue overlying the bony tissue lateral to the upper lateralcartilage.
 12. A method of stabilizing the upper lateral cartilage of apatient, the method comprising: creating an aperture in the mucosa ofthe patient; inserting the device of any of claims 1-11 into theaperture, wherein the body portion of the device is inserted into theaperture prior to the head portion; advancing the device into theaperture so that the head portion engages the upper lateral cartilage ofthe patient; engaging the plurality of barbs into a soft tissueoverlying a bony tissue proximal to the upper lateral cartilage of thepatient.
 13. The method of claim 12, wherein the body portion of thedevice pierces the upper lateral cartilage of the patient.
 14. Themethod of claim 12, wherein the body portion of the device is insertedbetween the upper lateral cartilage of the patient and bony tissueproximal to the upper lateral cartilage.
 15. The method of claim 12,wherein the device is inserted into the aperture using a guiding needlesheath.
 16. The method of claim 12, wherein engaging the plurality ofbarbs into the soft tissue overlying the bony tissue proximal to theupper lateral cartilage of the patient comprises pressing down on anepidermal tissue proximal to the device.
 17. The method of claim 12wherein the bony tissue is part of the orbital bone.
 18. The method ofclaim 12 wherein the bony tissue is part of the nasal bone.
 19. Themethod of claim 12 wherein the bony tissue is part of the maxilla. 20.The method of claim 12 wherein the bony tissue is lateral to the upperlateral cartilage of the patient.